Metastatic Castrate Resistant Prostate CancerNCT03236688
Detection of ARv7 in the Plasma of Men With Advanced Metastatic Castrate Resistant Prostate Cancer (MCRP)
An observational study of Metastatic Castrate Resistant Prostate Cancer, run by Exosome Diagnostics, Inc. at 1 site in United States.
Trial summary
Demonstrate detection of ARv7 splice variant transcripts from exosomes in the circulation of MCRPC patients pre and post treatment with selective Androgen pathway inhibitors (i.e. abiraterone and enzalutamide) Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metastatic Castrate Resistant Prostate Cancer
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Participants must have histologically confirmed diagnosis of adenocarcinoma of the prostate.
- Clinical or radiographic evidence of metastatic disease.
- Planned therapy with either enzalutamide or abiraterone acetate within the coming 6 weeks.
- Evidence of disease progression on or following most recent therapy as evidenced by the following:
- Radiographic evidence of disease progression as defined by one or more new bone scan lesions.
- Growth of soft tissue / visceral metastases to greater than one centimeter in longest diameter.
Show all 16Show fewer
- Progressive disease despite 'castration levels' of serum testosterone (<50ng/dL with continued androgen deprivation therapy.
- At least two of the following high risk features during screening for rapid disease progression:
- Anemia with a hemoglobin <12.0 g/dL
- Elevated alkaline phosphatase
- High lactate dehydrogenase (LDH)
- Presence of visceral metastasis on imaging
- Presence of clinically significant pain requiring opioid analgesics.
- PSA doubling time under 3 months on most recent therapy
- PSA values obtained 2 or more weeks apart, with last value being 2.0ng/mL or higher.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Receiving or intend to receive concurrent chemotherapy
- Hepatitis (all types) in patient's medical record
- HIV documented in patient's medical record
- History of intercurrent or past medical history or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
Demonstrate detection of ARv7 splice variant transcripts from exosomes in the circulation of MCRPC patients pre and post treatment with selective Androgen pathway inhibitors (i.e. abiraterone and enzalutamide)
Read the detailed description
Primary Objective
-Demonstrate detection of ARv7 splice variant transcripts from exosomes in the circulation of MCRPC patients pre and post treatment with selective Androgen pathway inhibitors (i.e. abiraterone and enzalutamide)
Secondary and Exploratory Objectives
- Correlate ARv7 status with PSA response (>/=50% decline in PSA level from baseline, maintained for >/=4 weeks) at any time after the initiation of therapy.
- Comparison of median progression free survival (PFS) and overall survival (OS).
- Determine additional molecular lesions in exoRNA and cfDNA in MCRPC patients post-treatment with androgen pathway inhibitors.
- Correlate other AR-variants (non ARv7) with clinical outcomes including PSA response.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MCRPC | Metastatic Castrate Resistant Prostate Cancer (MCRPC) Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of ARv7 splice variant in the circulation of MCRPC patients. PSA response rate in ARv7 positive patients.
The detection of ARv7 splice variants in samples will be considered both binary: positive or negative/not assessable and level based. ARv7 splice variants from exosomes will be detectable from baseline in 50% of both API; PSA response rates will be 10% or less in ARv7 positive patients. With a sample of 30 patients (as reported in the NEJM study) per cohort would allow the study to have an 85% power to detect a difference of 50 percentage points in PSA response rates, with the use of a two-sided test at an alpha level of 0.1.
Measured: Two years
Secondary outcomes (1)
Detection of ARv7 splice variant in the circulation of MCRPC patients. PSA response rate in ARv7 negative patients.
The detection of ARv7 splice variants in samples will be considered both binary: positive or negative/not assessable and level based. ARv7 splice variants from exosomes will be detectable from baseline in 50% of both API; PSA response rates will be 50% or more in ARv7 negative patients. With a sample of 30 patients (as reported in the NEJM study) per cohort would allow the study to have an 85% power to detect a difference of 50 percentage points in PSA response rates, with the use of a two-sided test at an alpha level of 0.1.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study startFeb 2016
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castrate Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exosome Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Roger Tun, Study director, Exosome Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236688
- Sponsor's protocol ID
- ECT2015-004
- Status last verified
- Oct 2022
- First submitted
- 23 Feb 2016
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of ARv7 in the Plasma of Men With Advanced Metastatic Castrate Resistant Prostate Cancer (MCRP)
- ClinicalTrials.gov ID
- NCT03236688
- Acronym / sponsor ID
- ECT2015-004
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Exosome Diagnostics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Study start
- Feb 2016
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demonstrate detection of ARv7 splice variant transcripts from exosomes in the circulation of MCRPC patients pre and post treatment with selective Androgen pathway inhibitors (i.e. abiraterone and enzalutamide)
Detailed description
Primary Objective
-Demonstrate detection of ARv7 splice variant transcripts from exosomes in the circulation of MCRPC patients pre and post treatment with selective Androgen pathway inhibitors (i.e. abiraterone and enzalutamide)
Secondary and Exploratory Objectives
- Correlate ARv7 status with PSA response (>/=50% decline in PSA level from baseline, maintained for >/=4 weeks) at any time after the initiation of therapy.
- Comparison of median progression free survival (PFS) and overall survival (OS).
- Determine additional molecular lesions in exoRNA and cfDNA in MCRPC patients post-treatment with androgen pathway inhibitors.
- Correlate other AR-variants (non ARv7) with clinical outcomes including PSA response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCRPC | – | –Metastatic Castrate Resistant Prostate Cancer (MCRPC) Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (16 listed)
- Participants must have histologically confirmed diagnosis of adenocarcinoma of the prostate.
- Clinical or radiographic evidence of metastatic disease.
- Planned therapy with either enzalutamide or abiraterone acetate within the coming 6 weeks.
- Evidence of disease progression on or following most recent therapy as evidenced by the following:
- At least two of the following high risk features during screening for rapid disease progression:
Key exclusion criteria (4 listed)
- Receiving or intend to receive concurrent chemotherapy
- Hepatitis (all types) in patient's medical record
- HIV documented in patient's medical record
- History of intercurrent or past medical history or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of ARv7 splice variant in the circulation of MCRPC patients. PSA response rate in ARv7 positive patients.
Time frame: Two years
The detection of ARv7 splice variants in samples will be considered both binary: positive or negative/not assessable and level based. ARv7 splice variants from exosomes will be detectable from baseline in 50% of both API; PSA response rates will be 10% or less in ARv7 positive patients. With a sample of 30 patients (as reported in the NEJM study) per cohort would allow the study to have an 85% power to detect a difference of 50 percentage points in PSA response rates, with the use of a two-sided test at an alpha level of 0.1.
1 secondary outcome
Detection of ARv7 splice variant in the circulation of MCRPC patients. PSA response rate in ARv7 negative patients.
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Castrate Resistant Prostate Cancer
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Tun study director
Exosome Diagnostics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castrate Resistant Prostate Cancer, run by Exosome Diagnostics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of ARv7 splice variant in the circulation of MCRPC patients. PSA response rate in ARv7 positive patients. (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.